GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Study on Safety and Tolerability of SAR425899 in Overweight to Obese Subjects and Type 2 Diabetes Mellitus Patients Not Requiring Anti-Diabetic Pharmacotherapy With an Optional 6-month Safety Extension Period

A Randomized, Comparative, Open Label Study to Assess the Safety and Tolerability of 3-arm, Parallel, Repeated Subcutaneous Dose Regimens of SAR425899 in Overweight to Obese Subjects and T2DM Patients Not Requiring Anti-diabetic Pharmacotherapy, With an Optional 6-month Safety Extension Period

Lead sponsor

Sanofi

Asset

SAR425899

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

—

Primary endpoints

•Gastrointestinal (GI) adverse events (AEs)•GI AEs

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03414736

Org study IDTDR15516

Secondary IDU1111-1205-1368UTN

Timeline

Milestones

Study start2018-01-19actual

Study first posted2018-01-30actual

Primary completion2018-10-05actual

Study completion2018-10-05actual

Last update posted2022-04-25actual

Assets

Investigational agents

SAR425899

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy.

•Patients who are motivated to lose weight.

Exclusion criteria

•Type 1 diabetes mellitus.

•Body mass index <27 kg/m2.

•Screening hemoglobin A1c (HbA1c; glycosylated hemoglobin) >7.0%.

•Previous treatment with glucose-lowering agent(s) (eg, insulin, thiazolidinediones, metformin, DPP-IV inhibitors (dipeptidylpeptidase 4), SGLT-2 (sodium dependent glucose transporter-2) inhibitors, etc) within the last 6 months.

•Previous treatment with glucagon-like peptide 1 (GLP-1) receptor agonists within the last 6 months.

•Uncontrolled hypertension.

•Laboratory findings at the time of screening: amylase and/or lipase >2 times the upper limit of the normal laboratory range (ULN), alanine aminotransferase >1.5 ULN, total bilirubin >1.5 ULN, serum creatinine levels ≥1.5 mg/dL [males]. ≥1.4 mg/dL [females], screening calcitonin ≥20 pmol/m, fasting serum triglycerides >400 mg/dL.

•Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC.

•History of weight loss surgery.

•History of pancreatitis or pancreatectomy.

•Pregnant or lactating women.

•Women of childbearing potential (WOCBP) not protected by highly-effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Glycemic / diabetes

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in body weight

Time frame:Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Change in fasting plasma glucose (FPG)

Time frame:Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in hemoglobin A1c (HbA1c)

Time frame:Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Frequency of gastrointestinal (GI) adverse events (AEs)

Time frame:Main study: Up to week 8; Six-month study extension period: Up to month 8

descriptive, event

Primary/protocol endpoint

Frequency of GI AEs

Time frame:Main study: Up to week 8; Six-month study extension period: Up to month 8

event count, event

Primary/protocol endpoint

Frequency of GI AEs

Time frame:Main study: Up to week 8; Six-month study extension period: Up to month 8

event count, event

Secondary/protocol endpoint

Adverse events (AEs)

Time frame:Main study: up to week 8; Six-month extension period: up to month 8

Treatment-emergent AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.